Stellar M22 For Intense Pulsed Light (IPL) And Laser System

Powered Laser Surgical Instrument

Lumenis Ltd.

The following data is part of a premarket notification filed by Lumenis Ltd. with the FDA for Stellar M22 For Intense Pulsed Light (ipl) And Laser System.

Pre-market Notification Details

Device IDK193500
510k NumberK193500
Device Name:Stellar M22 For Intense Pulsed Light (IPL) And Laser System
ClassificationPowered Laser Surgical Instrument
Applicant Lumenis Ltd. 6 Hakidma Street PO Box 240 Yokneam,  IL 2069204
ContactShlomit Segman
CorrespondentJonathan Kahan
Hogan Lovells US LLP 555 Thirteenth Street NW Washington,  DC  20004
Product CodeGEX  
Subsequent Product CodeONF
Subsequent Product CodeONG
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral & Plastic Surgery
510k Review PanelGeneral & Plastic Surgery
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-17
Decision Date2020-01-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290109144788 K193500 000
07290109144771 K193500 000

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